INFORMATION DOCUMENT INF79/3
Effective: 12/02/16
Instructions for use - ABO Cells
IVD
Reagent red cells for use in ABO & RhD grouping
for in vitro diagnostic use only
Product Codes: PR012, PR022, PR033, PR034 and PR044
Reagents, NHSBT Liverpool,
14 Estuary Banks, Liverpool L24 8RB
Tel 0151 268 7157
Intended use
These reagent red cells are intended to be used to test
plasma/serum samples to determine ABO group (reverse or
serum group). It is important to determine the ABO blood
group correctly in order to ensure that any subsequent
transfusion is as free from risk of a red cell transfusion
reaction as possible within the limits of the techniques used.
Principles of the examination method
An indivdual’s ABO type is usually determined by testing their
red cells with anti-A and anti-B to detect the presence of the A
& B antigens and testing their plasma or serum with A and B
cells to detect the presence of anti-A and anti-B.
Plasma/serum samples are incubated with reagent red cells
to determine the presence of agglutinins by direct methods.
Components
These reagents include A1 rr, A2 rr, B rr, O R1r and B R1r cells
and are pooled where indicated on the label.
These reagent red cells are supplied as 2.8±0.2% suspension
for the A1 rr, A2 rr, B rr, B R1r and O R1r to be used directly
from the vial.
These cells may be washed and resuspended before use in
phosphate buffered saline (PBS) pH 7 or in LISS to a
concentration appropriate to the method involved, but must be
discarded within 24 hours of preparation. The user is
responsible for assuring the strength of cell suspension and
the quality of PBS, LISS or any other suspension solution
used, and care should be taken to ensure that appropriate
serum to cell ratios are maintained in all test systems.
These reagent red cells, prepared from non-remunerated
donor blood, are leucodepleted, washed and suspended in
Modified Alsevers solution, which has been specially
formulated to preserve red cell integrity and antigenicity,
containing trisodium citrate (8 g/L), D-glucose (20.0g/L), citric
acid monohydrate (0.5g/L) sodium chloride (4.2g/L), inosine
(0.938g/L), ATP (0.4g/L), chloramphenicol (0.34g/L) and
neomycin sulphate (0.1g/L).
Reagent Preparation
Mix before use
Storage and shelf life after first opening
Store at 2 - 8oC.
Do not freeze.
Do not use beyond the notified expiry date
Warnings and precautions
For professional use only.
The recommended conditions of storage and use must be
rigidly applied.
Do not use if obviously discoloured or haemolysed.
Cells must not be pooled.
The donations used in this product have been tested at
source and found negative for the mandatory microbiological
tests required by the Guidelines for UK BTS at the time of
donation. No known test methods can offer assurances that
products derived from human blood will not transmit infectious
disease. Appropriate care should be taken in the use and
disposal of this product.
Chloramphenicol is classified as a carcinogen, neomycin
sulphate as an irritant.
Primary sample collection, handling and storage
Clotted serum or EDTA plasma samples may be used, usually
less than 7 days old, different time scales apply to recently
transfused patients.
Examination Procedure
Tube centrifugation (spin) method
1 Add cells to test serum/plasma in 1:1 ratio
2 Mix, incubate at RT for 5 minutes then centrifuge
3 Read macroscopically and record results
Control Procedure
Each batch of tests should be controlled with suitable positive
and negative controls.
Interpretation of results
The presence of agglutination indicates a positive result. If
anomalous ABO results are found, the grouping should be
repeated and include both O cells and auto controls.
Performance characteristics
The antigenic status of these cells has been deteremined
using, wherever possible, at least 2 examples of antisera
directed against that antigen.
Limitations of the examination procedure
If controls set up with the batch of tests fail to give the
required results then all tests must be repeated. Deviations
from these recommended methods must be validated by the
user. If these reagent red cells are used in a proprietary
system, the manufacturer’s recommended method must be
followed.
Literature references
These reagents comply with:
The requirements of Directive 98/79/EC on in vitro diagnostic
medical devices.
The recommendations contained in the current version of the
Guidelines for the Blood Transfusion Services in the UK.
Template Version 07/10/08)
Author(s) Dawn Wilcox
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